APPLICATION
ANDA080975
TYPE
ANDA
ORIGINAL APPROVAL
1972-12-26
LATEST ACTION
1991-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RESERPINEDiscontinued
RESERPINE 0.25MG · TABLET · ORAL
RESERPINEDiscontinued
RESERPINE 1MG · TABLET · ORAL
RESERPINEDiscontinued
RESERPINE 0.1MG · TABLET · ORAL
Approval history
1991-02-08Manufacturing (CMC) · Supplement 16AP
1984-10-03Manufacturing (CMC) · Supplement 9AP
1982-04-06Manufacturing (CMC) · Supplement 7AP
1972-12-26OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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